VistaPharm (Valley, PI)

Info

Is it safe and what are the pharmacokinetics of single and multiple doses of Oxycodone Oral Solution in pediatric and adolescent subject for post-operative pain?

This is a Phase IV, open-label, multicenter study to evaluate the pharmacokinetics and safety of Oxycodone Oral Solution in pediatric and adolescent subjects. This medication is approved by the Food and Drug Administration (FDA) for adults and is frequently used by doctors for pain control in children; however, it has not yet been approved by the FDA for use in children. After subjects transition from IV to oral pain medication, one dose of Oxycodone Oral Solution is administered in place of the standard analgesic medication, and patients are followed for 24 hours post-dosing.